Whitepapers

As Triton X-100 faces growing regulatory and sustainability challenges, biopharmaceutical manufacturers are evaluating alternatives for detergent-based viral inactivation. This whitepaper examines key considerations for replacing Triton X-100, including viral clearance, product quality, process compatibility, residual clearance, and implementation, while sharing data on J.T.Baker® Viral Inactivation Solution.

Discover how intrinsically enteric capsule technology helps simplify pharmaceutical manufacturing while protecting acid-sensitive APIs and enabling targeted oral drug delivery. This educational whitepaper explores the innovation behind next-generation enteric capsule technology.

A risk-based, scientifically justified approach to E&L assessment that protects patient safety, supports product quality, and stands up to global regulatory review. Pharmaceutical products come into contact with packaging systems, manufacturing equipment, process-contact materials, and delivery devices — and even trace-level compounds migrating from these materials can have meaningful implications for patient safety and product quality. With USP <1663>, <1664>, and <1665> and the draft ICH Q3E guideline shaping expectations, regulators increasingly expect a proactive, lifecycle-oriented approach to E&L. This white paper outlines how to design and execute an E&L program that meets those expectations. Download “Extractables and Leachables (E&L) Studies in Pharmaceutical Development” Discover: The difference between extractables (“What could come out?”) and leachables (“What does come out?”) — and how one informs the other How USP <1663>, <1664>, and <1665> and the draft ICH Q3E guideline shape today’s regulatory landscape Study design principles: solvent selection, surface-area-to-volume ratios, worst-case configurations, and alignment of leachables testing with stability programs Complementary analytical techniques (GC, LC, and ICP) and how results feed into toxicological evaluation Common challenges — complex matrices, very low reporting thresholds, unknown compounds — and the critical success factors for overcoming them Written by the R&D team at Fresenius Kabi’s international research and development center in Friedberg, Germany, where E&L studies are supported by close collaboration across analytical development, toxicological assessment, packaging expertise, and regulatory functions.

Early-phase drug development often stalls when development, manufacturing, and clinical activities operate independently. Learn how an integrated model can help address common bottlenecks, improve program continuity, and generate the data needed to make confident development decisions.

Formulate the right drug product, faster and with a higher probability of success: Quotient Sciences’ new proprietary AI solution combines our insight with the power of AI to achieve formulation decisions up to 50% faster.

As lipid nanoparticles advance across RNA therapeutics, gene editing, and other modalities, cholesterol is gaining greater attention. This whitepaper explores cholesterol’s impact on LNP structure, stability, morphology, and delivery, while examining excipient quality, impurity control, sourcing, and the emerging potential of plant-derived cholesterol.

As siRNA therapeutics expand into larger patient populations and commercial-scale indications, manufacturers face increasing pressure to deliver high-quality drug substance at greater scale, improve efficiency, and with improved sustainability. This case study highlights how Codexis and Bachem collaborated to advance RNA manufacturing through a modular, enzymatic approach that combines short-fragment synthesis with engineered ligases to overcome the limitations of traditional oligonucleotide manufacturing. Using vutrisiran as a model siRNA, the study demonstrates how optimized fragment and enzyme design via Codexis’s FragLinkSM can drive high ligation efficiencies, reduce purification burden, and enable scalable multi-kilogram GMP production. The result is a flexible manufacturing strategy that helps developers accelerate scale-up, improve manufacturing economics, and prepare for future commercial demand.

Enereductases (EREDs) and ketoreductases (KREDs) are highly selective enzymes that offer greener alternatives to more traditional asymmetric hydrogenation reactions. Enzyme cascades are a powerful way to enable more environmentally friendly and cost-effective synthetic processes for the manufacture of APIs. Here we report the discovery and development of an ERED/KRED biocatalytic cascade to enable efficient installation of the two stereocenters on a cyclohexyl ring for the synthesis of BMS-986278, a potent small-molecule LPA1 antagonist. A combination of protein engineering and process development optimized the cascade, resulting in orders of magnitude improvement over the original cascade proof-of-concept, and an over four-fold reduction in PMI over the first generation non-biocatalytic campaign for synthesis of the fragment. The synthesis of BMS-986278 was honored as a co-winner of the 2023 Peter J. Dunn award for Green Chemistry & Engineering Impact in the Pharmaceutical Industry, in large part because of the sustainability improvements enabled by this enzymatic cascade.

From next-generation biologics to smarter capsule technology and cleaner supplier communication, this ebook brings together 4 insights at where formulation science is headed and what it takes to get complex therapies safely from lab to patient. Inside, readers will find a look into the stability challenges of emerging biologics such as antibody-drug conjugates and bispecifics, including real-world case studies on taming viscosity and solubility at high concentrations. The industry's accelerating shift from IV to subcutaneous delivery is discussed, unpacking the regulatory approvals, patient-outcome data, and market forces turning at-home biologic dosing into standard practice. On the drug-delivery-innovation side, a feature on a novel capsule-in-capsule platform shows how liquid and solid actives can be combined in a single dose to cut pill burden without sacrificing performance. Rounding this eBook out, an IPEC-Americas explainer shows how the Excipient Information Package can replace slow, inconsistent supplier questionnaires with a standardized format that speeds qualification from months to days.

Pharmaceutical manufacturing laboratories must maintain reliable data, controlled processes, and regulatory readiness while supporting efficient quality operations. This white paper examines how a purpose-built, pre-validated LIMS can replace manual and disconnected workflows with integrated sample management, instrument connectivity, secure audit trails, and embedded quality-management capabilities. Learn how a modern LIMS can help improve data integrity, streamline laboratory operations, support compliant batch release, and protect product quality.

WHY A PURPOSE-BUILT LIMS? The Data Management Challenge A successful lab is more than a scientific hub. In today’s age, it’s a digital data enterprise. But should that platform be one-size-fits-all across industries? A pharma lab needs regulatory documentation, while a diagnostics lab requires advanced tracking of biospecimens. Traditionally, each would begin with the same basic building blocks: a Laboratory Information Management System (LIMS) with standalone point solutions such as an Electronic Laboratory Notebook (ELN) or a Laboratory Execution System (LES) daisy-chained together to approximate an end-to-end solution. Then, through a complex à-la-carte development and validation process, each of these labs would customize their platform in response to their divergent needs. Until now.

Are you putting your secondary packaging through its paces with 100% vision inspection technology? Learn what it takes to maintain the highest level of quality, as in 100%.

Colbert Packaging Executives Report on the State of the Secondary Packaging Industry and Why Independence Matters

Discover a novel technology to standardize purification across a broad range of microbial proteins that accelerates and streamlines microbial workflows. This new technology addresses a key bottleneck in microbial bioprocessing, enabling predictable, scalable, and accelerated manufacturing of next-generation biologics. Download the white paper to learn more.

Accelerate microbial bioprocess development with proven strategies that shorten timelines. Learn practical methods to de-risk scale-up from gene to GMP without compromising quality whilst enabling rapid, confident progression to robust, scalable and commercially viable processes.

Downstream processing can be the cause of a bottleneck in manufacturing, particularly for complex biologics, leading to a need for simpler platform approaches. In this technical interview, we discuss solutions that are being deployed to address this complicated challenge and a new, more simplified approach for a diverse subset of non-mAb therapies.  

As increasingly complex, poorly water-soluble molecules enter development, AustinPx helps developers look beyond near-term needs and select the right ASD technology for the full program. With spray drying, hot-melt extrusion, and KinetiSol™ under one roof, our team evaluates leading ASD approaches early and, on a drug-specific basis. Through comprehensive screening, optimization, biopharmaceutical analysis, and early manufacturing assessment, we help clients identify the right formulation and process before late-stage commitments are made, reducing the risk of reformulation, clinical delays, PK bridging studies, manufacturing constraints, and rising cost of goods while protecting scalability, patient experience, and long-term asset value.

An educational eBook exploring how continuous environmental monitoring systems help pharmaceutical and biopharmaceutical manufacturers achieve and maintain FDA, GMP, and 21 CFR Part 11 compliance.

A practical checklist walking pharmaceutical and lab quality teams through the seven key considerations for selecting a compliant, scalable, environmental monitoring system.

An educational article on how precise temperature and humidity control protects biopharmaceutical product stability, supports FDA 12 CFR part 11 compliance, and reduces manufacturing risk.

An educational article examining how continuous environmental monitoring protects sample integrity across every phase of the drug development lifecycle, from discovery and preclinical research through clinical trials and post-market surveillance.

This Quality and Regulations eBook, presented by PharmTech, PharmTech Europe, and BioPharm International® is your guide to quality and compliance strategy, covering everything from ICH Q5A(R2)'s viral safety expectations to what a real FDA warning letter reveals about AI's limits in GMP documentation. Industry leaders discuss how risk-based quality frameworks are accelerating biopharma development, alongside a look at how USP's digital standards are modernizing quality control labs without sacrificing rigor. This eBook offers a practical roadmap for building quality systems ready for 2026's regulatory landscape and beyond.

Aseptic processing by design: The flexible and efficient use of RABS and Isolators

Delivering clinical supplies into the European Union and United Kingdom requires rigorous oversight from a QP to ensure every batch meets regulatory, GMP, and trial-specific requirements. Yet, many sponsors face preventable delays, often due to incomplete documentation, limited supply chain visibility, or late communication of changes. This paper breaks down the core responsibilities of the QP, explains how European Union and United Kingdom expectations differ, and share practical steps sponsors can take to streamline the certification process. Readers will learn how to prepare audit-ready documentation, avoid common pitfalls that extend release timelines, and build efficient collaborations with QPs to keep studies moving without interruption.

The development and manufacturing of innovative drug products, particularly those involving protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant hurdles. A primary challenge lies in designing scalable manufacturing processes that meet production demands while ensuring stability and bioavailability. Traditional methods often fall short when handling advanced therapeutic modalities, resulting in limitations in production volume, product consistency, and manufacturability. Addressing these limitations is critical to bringing novel therapies to market effectively and at scale. Spray drying has emerged as a scalable and consistent manufacturing process for producing drug product intermediates. This paper explores the use of spray drying to overcome manufacturing bottlenecks and enhance development across a wide range of drug products.

Catalent’s micronization services help innovators overcome the toughest drug development challenges. Our high-containment facilities and expert scientists deliver consistent particle size reduction, high API recovery, and audit-ready processes to support early-phase clinical programs. Whether your project requires potent API handling, rapid turnaround, or extended analytical verification, Catalent combines speed, precision, and compliance to keep your milestones on track. Gain insights into real-world case studies that demonstrate how our structured, transparent approach ensures reliable delivery while protecting your valuable APIs. Discover why leading pharmaceutical and biotech companies choose Catalent as their trusted CDMO partner for micronization.

Pharmaceutical micronization, the process of reducing particle size to the micrometer scale, has become a critical technology for improving drug solubility, bioavailability, and formulation flexibility. Catalent, a global leader in drug development and delivery solutions, offers world-class micronization services through its specialized facilities in Dartford, UK, and Malvern, Pennsylvania, USA, supported by a network of forward processing commercial-scale manufacturing sites. This article explores the advantages of micronization and how Catalent’s integrated approach accelerates drug development.

Modern drug development faces a two-part pressure test: molecules are getting harder to formulate, and global manufacturing routes are getting harder to rely on. Poor water solubility and limited physical stability continue to delay many small-molecule and peptide programs, while shifting trade policies, logistics constraints, and onshoring pressure increase the cost and risk of fragmented supply chains. Sponsors need formulation strategies that improve performance and also translate cleanly to robust, predictable manufacturing. This paper explores how integrating large-scale domestic spray drying capacity earlier in development can accelerate timelines, lower costs, and strengthen portfolio resilience in an unpredictable global landscape. It outlines how this approach supports rapid development, enhances cost efficiency for high-volume therapies, and mitigates risks tied to international manufacturing disruptions.